In July 2016, revision 4 of the MEDDEV 2.7/1 guidelines was released to much anticipation within the medical device community. The document has been expanded and now contains expanded details on requirements that effect almost every aspect of the clinical evaluation of medical devices with CE-mark. So what do you need to know to make sure your organization is in compliance?
The fundamentals haven’t changed; the manufacturer still must use clinical data to establish the safety and performance as intended of the target medical device; demonstrate conformity to Essential Requirements; appraise and analyze clinical data. However—and this is where things change slightly—the level of detail, acceptable methods, and applicable timeframes are new.
10 Implications to Medical Device Companies caused by the MedDev v4 Requirements
- Stricter Qualifications for Authors and Evaluators: Authors and Evaluators must be properly qualified. Each evaluator must have an advanced science or related academic degree, combined with five years of related professional experience, or 10 years’ professional experience if that individual is lacking an advanced degree. Additionally, each evaluator must complete a Declaration of Interest statement.
- Stricter Requirements for Demonstration of Device Equivalency: Manufacturers may no longer choose multiple comparator devices unless the equivalence of each device can be established to the target device across all three equivalence parameters—clinical, technological, and biological. In other words, each comparator device must stand on its own as equivalent to the target device.
- Access to Data for Equivalent Devices: Revision 4 requires the Notified Body challenge the manufacturers access to data on the equivalent device(s). Therefore on competitor devices in which equivalence is claimed, manufacturers must have a contract in place allowing for access to the clinical and non-clinical data for that device.
- Scientific Validity: There is now a greater emphasis on the scientific validity of the data. This includes demonstration of rigorous appraisal and analysis of all available clinical data.
- Frequency of CER Updates: The new MEDDEV guidelines make it clear that the Clinical Evaluation Report (CER) must be completed during pre-market phase before placing the device on the market. Once the product is on the market the CER must be updated regularly to demonstrate the continued safety and performance of the device—annually for high risk or new devices, and two to five years on for lower risk devices. Any deviation from this frequency must be clearly justified by the manufacturer.
- Specific Measureable Objectives for the CER: In Revision 3 of MEDDEV there were requirements of the manufacturer to document the objectives and scope of the CER. Additionally, it was required to define terms of safety and risk endpoints in relation to Essential Requirements. While this is still a requirement there has been additional guidance on how to analyze clinical data to demonstrate compliance with the Essential Requirements of European Council Directives MDD 93/42/EEC or AIMDD 90/385/EEC.
State of the Art Establishment: Clause 8.2 now provides greater detail establishing state-of-the-art documentation and other available treatment options.
- Risk-Benefit Profile: Appendix 7 provides detailed guidance on the analysis of data to demonstrate device safety and performance. Appendix 7.2 discusses the risk-benefit profile in particular, including the evaluation and quantification of benefits and risks, and the evaluation of the overall risk-benefit profile. The value of post-market data, and factors which could affect the statistical validity of the evaluation of this data, are addressed in some detail.
- Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF): The links between clinical evaluations, PMS and PMCF are reinforced throughout Revision 4. Additionally, it is a requirement for Notified Bodies to ensure that PMCF is planned and appropriately justified in light of the clinical data, risk/benefit analysis and conclusions documented in the CER.
What it Means for You
It is imperative for your organization to understand the new MEDDEV guideline changes and clarifications in order to ensure the compliance of your Clinical Evaluation Reports with these new requirements.
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